BOne marrow transfer to enhance ST-elevation infarct regeneration-2 - BOOST-2

Apr 26, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
German Research Foundation
Date Published:
04/19/2017
Original Posted Date:
04/26/2017
References

Contribution To Literature:

The BOOST-2 trial failed to show that intracoronary injection of bone marrow cells (BMCs) improved left ventricular ejection fraction (LVEF).

Description:

The goal of the trial was to evaluate treatment with intracoronary injection of nucleated bone marrow derived cells compared with placebo among patients with ST-segment elevation myocardial infarction (STEMI).

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded

Patients with large STEMI were randomized to low-dose BMC infusion (loBMCi; n = 38) versus high-dose BMC infusion (hiBMCi; n = 39) versus low-dose irradiated BMC infusion (loBMCi; n = 36) versus high-dose irradiated BMC infusion (hiBMCi; n = 38) versus placebo (n = 37).

  • Total number of enrollees: 188
  • Duration of follow-up: 6 months
  • Mean patient age: 55 years
  • Percentage female: 8%
  • Percentage with diabetes: 23%
  • Mean baseline LVEF: 45%

Principal Findings:

The primary outcome, change in LVEF at 6 months versus placebo, was 0.5% for loBMCi (p = 0.76), 1.0% for hiBMCi (p = 0.57), 1.2% for loBMCi (p = 0.55), and -0.2% for hiBMCi (p = 0.91).

For the secondary outcome, LV end-diastolic volume index was the same among all treated patients.

Interpretation:

Among patients with large STEMI and mildly reduced LVEF, intracoronary injection of clonogenic or non-clonogenic BMCs did not improve LVEF at 6 months.

References:

Wollert KC, Meyer GP, Müller-Ehmsen J, et al. Intracoronary autologous bone marrow cell transfer after myocardial infarction: the BOOST-2 randomised placebo-controlled clinical trial. Eur Heart J 2017;Apr 19:[Epub ahead of print].

Keywords: Acute Coronary Syndrome, Bone Marrow, Bone Marrow Cells, Heart Failure, Myocardial Infarction, Stroke Volume, Ventricular Function, Left


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